CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Deep Brain Stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00367003
NCT00367003N/ACompleted
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Deep Brain Stimulation for Treatment Resistant Depression

Emory University·interventional·Posted Aug 22, 2006·Updated Jun 23, 2026

In Brief

A clinical study evaluating Deep Brain Stimulation for Major Depressive Disorder. Completed, enrolled 37 participants across 1 site.

Detailed Summary

The purpose of this study is to test the safety, efficacy and mechanism of action of subgenual cingulate (Cg25) deep brain stimulation (DBS) for major depression in patients who have not responded to prior antidepressant treatments. Participation in the study will continue for ten years or until the device receives FDA approval for depression. Forty (40) patients will be enrolled in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsThe Dana Foundation

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 22, 2006
Enrollment StartSep 1, 2006
Primary CompletionJan 2, 2014
Study CompletionJun 14, 2024
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 19.9 years ago

Interventions

Deep Brain Stimulationdevice

The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary.